Vaccine against covid‑19 solution for injection, suspension
(ChAdOx1‑S [recombinant])
What Vaxzevria is and what it is used for
Vaxzevria is a vaccine used to prevent covid‑19, which is caused by the virus et SARS‑CoV‑2.
It is given to adults who are 18 years of age and older.
The vaccine stimulates the body’s natural defense mechanisms (the immune system). The vaccine works by making the body produce protection ( antibodies and specialized white blood cells ) against the virus that causes covid‑19, which protects covid‑19. None of the ingredients in this vaccine can cause covid‑19.
What you need to know before Vaxzevria is given to you
The vaccine must not be given to you:
- if you are allergic to the active substance or any other ingredient in this vaccine (listed in section 6).
- if you have had a blood clot while having low levels of platelets (thrombotic thrombocytopenic syndrome, TSS) after receiving Vaxzevria.
- if you have previously been diagnosed with capillary leak syndrome (a disease that causes fluid to leak from small blood vessels).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before Vaxzevria is given to you:
- if you have previously had a serious, life-threatening allergic reaction to another vaccine or if you have had an allergic reaction to the first injection with Vaxzevria;
- if you have ever fainted after a needle injection;
- if you have a high fever (over 38°C) or severe infection. However, you can get your vaccination if you have a mild fever or a mild upper respiratory tract infection such as a cold;
- if you have problems with bleeding or bruising easily, or if you are taking anticoagulants (to prevent blood clots);
- if your immune system does not work as it should (immune deficiency) or if you take drugs that weaken the immune system (such as corticosteroids in high doses, so-called immunosuppressive drugs, or cancer drugs);
- if you have previously developed Guillain-Barré syndrome (temporary loss of feeling and movement) after receiving Vaxzevria.
- if you have previously had transverse myelitis ( inflammation of the spinal cord) after receiving Vaxzevria.
If you are not sure if any of the above apply to you, talk to your doctor, pharmacist, or nurse before the vaccine is given to you.
As with all vaccines, vaccination with 2 doses protects you from Vaxzevria
possibly not all who are vaccinated. It is also not known how long the protection lasts.
Blood disorders
Very rare cases of blood clots combined with low levels of platelets, in some cases accompanied by bleeding, have been observed after vaccination with Vaxzevria. This included some serious cases of blood clots in unusual places in the body (eg brain, bowel, liver, spleen ) and increased clotting or bleeding around the body. The majority of these cases occurred within the first three weeks after vaccination. Some cases had fatal outcomes. Fewer cases have been reported after the second dose than after the first dose.
Blood clots in the brain unrelated to low levels of platelets have been observed in very rare cases after vaccination with Vaxzevria. The majority of these cases occurred within the first four weeks after vaccination. Some cases had fatal outcomes.
Very low levels of platelets (immunological thrombocytopenia ), which may occur together with bleeding, have been reported in very rare cases, usually within the first four weeks after vaccination with Vaxzevria.
Seek emergency care immediately if you experience difficulty breathing, chest pain, swelling of a leg, pain in a leg, or persistent stomach pain after vaccination (see section 4).
Also seek emergency care immediately if, after a few days after vaccination, you experience severe or persistent headache, blurred vision, confusion, or seizures after vaccination, or if you have unexplained bleeding or bruising or punctate bleeding in the skin or mucous membranes outside the vaccination site, which appears after a few days (see section 4).
Capillary leak syndrome
Very rare cases of capillary leak syndrome (CLS) have been reported following vaccination with Vaxzevria. Some affected patients had previously been diagnosed with CLS. Capillary leak syndrome is a serious, potentially life-threatening condition that causes fluid to leak from small blood vessels ( capillaries ), leading to rapid swelling of the arms and legs, sudden weight gain, and feeling faint (low blood pressure ). Seek immediate medical attention if you develop these symptoms in the days following vaccination.
Adverse effects on the nervous system
Guillain-Barré syndrome ( GBS ):
See a doctor immediately if you experience weakness and paralysis in the arms or legs which may spread to the chest and face (Guillain-Barré syndrome). This has been reported in very rare cases after vaccination with Vaxzevria.
Inflammation of the spinal cord (transverse myelitis ), TM:
See a doctor immediately if you experience weakness in the arms and legs, sensory symptoms (such as tingling, numbness, pain, or loss of pain sensation), or problems with bladder or bowel function. This has been reported in very rare cases after vaccination with Vaxzevria.
Risk of very rare side effects after a booster dose
The risk of very rare side effects (eg blood disorders, including thrombotic thrombocytopenic syndrome, CLS, GBS, and TM) after a booster dose of Vaxzevria is unknown.
Children and young people
Vaxzevria is not recommended for children under 18 years of age. There is currently insufficient information available on the use of Vaxzevria in children and adolescents under 18 years of age.
Other medicines and Vaxzevria
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines or vaccines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before receiving this vaccine.
Driving ability and use of machinery
Some of the side effects of Vaxzevria listed in section 4 (Possible side effects ) may temporarily impair your ability to drive and use machines. If you feel unwell after the vaccination, you should not drive or use machinery. Wait until any side effects from the vaccine have passed before driving or using machinery.
Vaxzevria contains sodium and alcohol (ethanol)
This medicine contains less than 1 mmol (23 mg) of sodium per dose of 0.5 ml, i.e. it is almost “sodium-free”.
This medicine contains 2 mg of alcohol ( ethanol ) per dose of 0.5 ml. The low amount of alcohol in this medicine does not produce any noticeable effects.
How Vaxzevria is given
Vaxzevria is given as an injection of 0.5 ml into a muscle (usually in the upper arm).
During and after each injection of the vaccine, the doctor, pharmacist, or nurse will keep you under observation for about 15 minutes to check for signs of an allergic reaction.
Primary vaccination series
You will receive 2 injections of Vaxzevria. The second injection can be given between 4 and 12 weeks after the first injection. You will be informed when to come back for your second injection.
If you miss an appointment for your second injection of Vaxzevria
If you miss a scheduled vaccination appointment, ask your doctor, pharmacist, or nurse for advice. You must return for your second injection of Vaxzevria. If you miss a scheduled vaccination, you may not be fully protected against covid‑19.
Booster dose
You can get a booster injection of Vaxzevria. The booster injection can be given at least 3 months after you complete the primary vaccination series with Vaxzevria or an approved mRNA covid‑19 vaccine.
Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
In clinical studies, most side effects were mild or moderate and resolved within a few days. After the second dose, fewer side effects were reported.
After vaccination, you may experience more than one side effect at the same time (eg muscle/joint pain, headache, chills, and general malaise). If any of your symptoms persist, consult a doctor, pharmacist, or nurse.
Blood clots in combination with low levels of platelets (thrombotic thrombocytopenic syndrome, TSS) have been reported in very rare cases, see section 2.
See your doctor immediately if you experience any of the following symptoms within three weeks of vaccination:
- experience a severe or persistent headache, blurred vision, confusion, or seizures
- have difficulty breathing, chest pain, swelling in a leg, pain in a leg or persistent stomach pain
- notice unusual bruises or small, round spots in places other than the vaccination site
Seek medical attention immediately if you experience symptoms of a severe allergic reaction. Such reactions may involve one or more of the following symptoms:
- feel faint or dizzy
- changes in your heart rhythm
- respiratory distress
- wheezing
- swelling of the lips, face, or throat
- hives or skin rash
- nausea or vomiting
- stomach pain.
The following side effects can occur with Vaxzevria:
Very common (may affect more than 1 in 10 users)
- tenderness, pain, warmth, itching, or bruising where the injection is given
- tiredness or general malaise
- chills or feel feverish
- headache
- nausea
- joint pain or muscle pain
Common (may affect up to 1 in 10 users)
- swelling or redness where the injection is given
- fever (≥ 38 °C)
- vomiting or diarrhea
- mild and transient decreased level of platelets (laboratory findings)
- pain in arms or legs
- flu-like symptoms, e.g. fever, sore throat, runny nose, cough, and chills
- physical weakness or lack of energy
Uncommon (may affect up to 1 in 100 users)
- sleepiness, feeling dizzy, or deep sleep and inactivity
- stomach pain or decreased appetite
- enlarged lymph nodes
- excessive sweating, itchy skin, rash or hives
- muscle spasms
- unusual sensation in the skin, e.g. tingling or crawling ( paresthesia )
- reduced sensation or sensitivity, especially in the skin ( hypesthesia )
- constant ringing in the ears ( tinnitus )
Rare (may affect up to 1 in 1,000 users)
- unilateral facial paralysis
Very rare (may affect up to 1 in 10,000 users)
- blood clots often in unusual places (eg brain, intestine, liver, spleen ) combined with low levels of platelets
- severe nerve inflammation that can cause paralysis and difficulty breathing ( Guillain-Barré syndrome [GBS])
Has been reported (occurring in an unknown number of users)
- severe allergic reaction ( anaphylaxis )
- hypersensitivity
- rapid swelling under the skin in areas such as the face, lips, mouth, and throat (which may cause difficulty swallowing or breathing)
- capillary leak syndrome (a disease that causes fluid to leak from small blood vessels)
- very low levels of platelets (immunological thrombocytopenia ) which may occur together with bleeding (see section 2, Blood disorders)
- blood clots in the brain are not associated with low levels of platelets (see section 2, Blood disorders)
- inflammation of the spinal cord (transverse myelitis )
How to store Vaxzevria
Keep this medicine out of the sight and reach of children.
Doctors, pharmacists, or nurses are responsible for storing the vaccine and for disposing of unused medicine correctly. The following information on storage, expiration date, use and handling, and disposal is intended for healthcare professionals.
Do not use this vaccine after the expiry date which is stated on the label after EXP.
Store in a refrigerator (2°C‑8°C).
Do not freeze.
Store the vials in the outer carton. Light sensitive.
Use within 6 hours from the time of first opening (first needle puncture) when stored at temperatures up to 30 °C. After this time, the vial must be discarded. Do not put it back in the refrigerator. Alternatively, an opened vial can be stored in a refrigerator (2°C-8°C) for up to 48 hours if it is returned to the refrigerator immediately after each puncture.
Discard the vial if the suspension is discolored or contains visible particles. Do not shake.
Contents of the packaging and other information
Contents declaration
One dose (0.5 ml) contains:
Chimpanzee adenovirus encoding SARS-CoV-2 spike glycoprotein et ChAdOx1‑S *, at least 2.5 × 10 8 infectious units
* Produced in genetically modified human embryonic kidney cells (HEK 293 cells) and by recombinant DNA technology.
This product contains genetically modified organisms (GMOs).
Other ingredients are L‑histidine, L‑histidine hydrochloride monohydrate, magnesium chloride hexahydrate, Polysorbate 80 (E 433), ethanol, sucrose, sodium chloride, disodium edetate (dihydrate), water for injections (see section 2 “Vaxzevria contains sodium and alcohol”).
Appearance and package sizes of the medicine
Solution for injection, suspension ( injection ). Suspension one is colorless to slightly brown and clear to slightly opaque.
Package sizes:
- Multidose a vial of 8 doses (4 ml) with a stopper (elastomer with aluminum seal) in a pack of 10 vials. Each vial contains 8 doses of 0.5 ml.
- Multi-dose vial of 10 doses (5 ml) with stopper (elastomer with aluminum seal) in a pack of 10 vials. Each vial contains 10 doses of 0.5 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
AstraZeneca Nijmegen BV
Lagelandseweg 78
Nijmegen, 6545CG
Netherlands
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
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